Food Safety Report: FDA warning letter to Oceanitan, Inc.

2937 East Pico Boulevard, Los Angeles, 90023 California, United States

The FDA released a warning letter for Oceanitan, Inc., on September 7, 2023.

The FDA inspected Oceanitan, Inc. located at 2937 E Pico Blvd, Los Angeles, CA 90023 on February 16, 2023, through April 6, 2023. This facility is involved in contract manufacturing refrigerated ready-to-eat (RTE) baby food products in reduced oxygen packaging (ROP). This action follows a consumer complaint related to a case of infant botulism.

The FDA's inspection findings and analytical results for finished product samples have led to the determination that the RTE ROP baby food products manufactured at the facility are adulterated. This determination arises from the preparation, packing, or holding of these products under conditions that may have caused contamination or pose health risks. Additionally, the facility's failure to comply with the preventive controls provisions of the CGMP & PC rule.

Furthermore, the warning letter highlights significant violations of food labeling regulations, rendering certain baby food products as misbranded.

The FDA received a written response from Oceanitan, Inc. on April 27, 2023, outlining corrective actions taken and planned by the company. However, the FDA has expressed ongoing concerns and provided detailed information on the violations discovered at the facility in the warning letter.

The violations identified in the warning letter can be categorized into three main areas:

1. Hazard Analysis and Risk-Based Preventive Controls:

- Failure to identify and evaluate hazards, such as bacterial growth and toxin formation due to reduced oxygen packaging (e.g., Clostridium botulinum).
- Failure to control the growth and/or toxin formation of C. botulinum, a known hazard in the baby food products.
- Inadequate temperature controls in storage, posing a risk of C. botulinum toxin formation.

2. Implementation of Written Procedures for Monitoring Preventive Controls

- Failure to properly implement and document procedures for monitoring preventive controls, particularly in the cooling step of the manufacturing process.
- Inaccurate critical limits and monitoring frequency in preventive control procedures.

3. Current Good Manufacturing Practice

- Facility cleanliness issues, including water dripping from condenser units contaminating food-contact surfaces.
- Inadequate repairs and maintenance of facility infrastructure.

Additionally, misbranding violations were noted, including the failure to declare nutrition information and the incorrect listing of ingredients on product labels.

The FDA has provided Oceanitan, Inc with an opportunity to address these concerns and prevent future violations. Failure to do so may result in legal actions, such as seizure and injunction.

The warning letter concludes with comments addressing other regulatory issues, including a request for adequate validation of cooking parameters and the proper declaration of net quantity of contents and ingredient listings on product labels.

Source: www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/oceanitan-inc-658436-09072023

About FDA Warning letters: "When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform the FDA of its plans for correction.".